Trial Outcomes & Findings for Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants (NCT NCT02819050)
NCT ID: NCT02819050
Last Updated: 2021-12-10
Results Overview
Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
7 days
Results posted on
2021-12-10
Participant Flow
Participant milestones
| Measure |
Sprinting
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
Baseline characteristics by cohort
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.4 Weeks
n=5 Participants
|
33.2 Weeks
n=7 Participants
|
33.3 Weeks
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysMeasured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Number of Participants With Successful Wean Off CPAP at the First Attempt
|
31 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 1-2 monthsMeasured as an oxygen requirement at 36 weeks corrected gestational age
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Number of Participants With Bronchopulmonary Dysplasia
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 1-2 monthsMeasured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Number of Participants With Retinopathy of Prematurity (ROP)
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 1-2 monthsMeasured as radiologic findings of PVL noted prior to discharge
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Number of Participants With Periventricular Leukomalacia (PVL)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 60-108 daysMeasures as the number of days patient remained hospitalized after birth at the study hospital.
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Length of Stay (Days)
|
82.5 Days
Interval 60.5 to 103.3
|
78 Days
Interval 62.0 to 108.0
|
SECONDARY outcome
Timeframe: 36weeks-41weeksMeasured as the corrected gestational age at which the patient was discharged or transferred.
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Corrected Gestational Age at Time of Discharge/Transfer
|
33.4 weeks
Interval 28.7 to 41.4
|
33.2 weeks
Interval 29.9 to 36.6
|
SECONDARY outcome
Timeframe: Until completely weaned off CPAPNumber of attempts made to wean off CPAP
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Number of Attempts to Wean Off CPAP
|
1 Attempt
Interval 1.0 to 2.0
|
1 Attempt
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 7-10 daysMeasured as the total number of days the patient was on the study protocol
Outcome measures
| Measure |
Sprinting
n=40 Participants
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
NCPAP: Nasal Continuous Positive Airway Pressure
|
Non-Sprinting
n=40 Participants
* If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
* If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
NCPAP: Nasal Continuous Positive Airway Pressure
|
|---|---|---|
|
Number of Days on Protocol
|
7 Days
Interval 7.0 to 7.0
|
7 Days
Interval 7.0 to 10.0
|
Adverse Events
Sprinting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Sprinting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Virender Rehan
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Phone: 3102221965
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place